510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K972812Substantially Equivalent

Raichem Prealbumin Spia

Hemagen Diagnostics, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972812 is the FDA 510(k) clearance record for RAICHEM PREALBUMIN SPIA, a class I device, cleared for Hemagen Diagnostics, Inc. on under FDA product code DDS (Prealbumin, Fitc, Antigen, Antiserum, Control). FDA records list 52 510(k) clearances for Hemagen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K972812.

Clearance record

Decision date
Received
(31 days to decision)
Product code
DDS Prealbumin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5060
Device class
Class I
Review panel
Immunology
Applicant
Hemagen Diagnostics, Inc. 34-40 Bear Hill Rd., Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code DDS

Trailing 12 months

FDA records hold no clearances under product code DDS in the trailing twelve months.

FDA records show no clearances under product code DDS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DDS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260